Regulatory PathRegulatory requirements compared

Active substance

Daraxonrasib

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
RASONQUE100MG; 150MGtablet · oralREVOLUTION MEDICINESPrescription26 Aug 2026

EMA European Union — centrally authorised medicines

Rasonque Revolution Medicines Netherlands B.V. · Opinion · ATC L01XX

Therapeutic indication (EMA)

Treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.

Updated